| September 12, 2006 |
| August 17, 2009 |
| March 2007 |
| March 2011 (final data collection date for primary outcome measure) |
- Modified Von Korff Pain Scale for low back pain [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
- Modified Von Korff Disability Scale [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
|
- Modified Von Korff Pain Scale for low back pain
- Modified Von Korff Disability Scale
|
| Complete list of historical versions of study NCT00376350 on ClinicalTrials.gov Archive Site |
- Pain days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
- Disability days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
- Low back pain unpleasantness [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
- Fear avoidance beliefs [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
- General health status/QoL [ Time Frame: baseline 2; 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
- Patient satisfaction [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
- Healthcare utilization [ Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
- Objective measures [ Time Frame: Baseline 2, 6 wk ] [ Designated as safety issue: No ]
- Bias monitoring [ Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
|
- Pain days
- Disability days
- Low back pain unpleasantness
- Fear avoidance beliefs
- General health status/QoL
- Patient satisfaction
- Healthcare utilization
- Objective measures
- Bias monitoring
|
| |
| Dose of Spinal Manipulation for Chronic Low Back Pain |
| Dose-Response/Efficacy of Manipulation for Chronic LBP |
This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation. |
| |
| Phase II, Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
| Low Back Pain |
- Procedure: Spinal Manipulation
- Procedure: Light Massage
- Procedure: Pulsed Ultrasound
|
- Experimental: High dose spinal manipulation + ultrasound
- Experimental: Moderate dose manipulation + low dose massage + ultrasound
- Experimental: low dose spinal manipulation + moderate dose massage + ultrasound
- Other: high dose massage = ultrasound
|
| Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83. |
| |
| Recruiting |
| 400 |
| March 2011 |
| March 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Current episode of low back pain
- mechanical origin
- Threshold low back pain level
Exclusion Criteria:
- Contraindications to spinal manipulation or massage
- Complicating conditions that could confound clinical outcome
- Prophylactic use of prescription medication
- Health-related litigation, claims, or disability compensation
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00376350 |
| Joseph Brimhall, Western States Chiropractic College |
| U01 AT001908 |
| National Center for Complementary and Alternative Medicine (NCCAM) |
|
| Principal Investigator: |
Mitchell Haas, DC, MA |
Western States Chiropractic College |
|
|
| National Center for Complementary and Alternative Medicine (NCCAM) |
| August 2009 |
